EMA — authorised 22 August 2024
- Application: EMEA/H/C/005647
- Marketing authorisation holder: Merck Sharp & Dohme B.V.
- Local brand name: Winrevair
- Indication: Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III and IV.
- Pathway: orphan, PRIME
- Status: approved
The European Medicines Agency (EMA) has approved WINREVAIR for the treatment of pulmonary arterial hypertension (PAH) in adult patients. This approval was granted on 22 August 2024, under the orphan and PRIME expedited pathways. WINREVAIR is indicated for use in combination with other PAH therapies for patients with WHO Functional Class II, III, and IV PAH.